Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK Biologicals'Kinrix · 1 trial · 3 indications
Anti-diphteria (anti-D) and anti-tetanus (anti-T) booster response was defined as: * initially seronegative subjects (sero-) (pre-booster antibody concentration below cut-off of \< 0.1 international units per milliliter (IU/mL)) with an increase of at least four times the cut-off one month after vaccination (post-booster antibody concentration ≥0.4 IU/mL) * initially seropositive subjects (sero+) (pre-booster antibody concentration ≥0.1 IU/mL) with an increase of at least four times the pre-booster antibody concentration one month after vaccination
anti-PT, anti-FHA and anti-PRN booster response : * initially sero- (pre-booster antibody concentration below cut-off \< 5.0 EL.U/mL) with increase of at least four times cut-off one month after vaccination (concentration post-booster ≥20.0 EL.U/mL) * initially sero+ with pre-booster antibody concentration ≥5.0 EL.U/mL and \< 20.0 EL.U/mL with increase of at least four times pre-booster concentration one month post-booster * initially sero+ with pre-booster antibody concentration ≥20.0 EL.U/mL with an increase of at least two times the pre-booster antibody concentration one month post-booster
Titers are expressed as GMTs.
| Arm | Type | Description |
|---|---|---|
| Kinrix + M-M-R II + Varivax | EXPERIMENTAL | Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively. |
| Kinrix + M-M-R II -> Varivax | ACTIVE_COMPARATOR | Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm. |
| Name | Type | Description |
|---|---|---|
| GSK Biologicals'Kinrix® | BIOLOGICAL | One dose as intramuscular injection at visit 1 |
| Merck and Company's MMRII | BIOLOGICAL | One dose as subcutaneous injection at visit 1 |
| Merck and Company's Varivax | BIOLOGICAL | One dose as subcutaneous injection at visit 1 or at visit 2 |
Inclusion Criteria: * Subjects for whom the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol. * A male or female child between 4 and 6 years of age, inclusive. * Written informed consent obtained from the parent or guardian of the subject...
GSK Biologicals'Kinrix is a vaccine developed by GSK plc for the prevention of tetanus, diphtheria, and acellular pertussis. It is studied in children four to six years of age. The product is also written as GSK Biologicals'Kinrix®. Its clinical development has reached Phase 3.
GSK Biologicals'Kinrix is used for protection against tetanus, along with diphtheria and acellular pertussis, in young children. Its Phase 3 trial enrolled healthy children aged four to six years in the United States. The trial conditions listed tetanus, acellular pertussis, and diphtheria.
GSK Biologicals'Kinrix is made by GSK plc, which trades under the ticker GSK. GSK is the developer of the vaccine and sponsored its clinical trial in healthy children. The product is also referred to as GSK Biologicals'Kinrix®.
GSK Biologicals'Kinrix has reached Phase 3 clinical development. Its single recorded trial, NCT00871117, is a completed Phase 3 study, so the vaccine remains an investigational product rather than a marketed one based on this development record.
GSK Biologicals'Kinrix has been studied in one completed Phase 3 trial, NCT00871117, titled Immunogenicity and Safety of Kinrix + (Measles Mumps Rubella) MMR Vaccine With and Without Varicella Vaccine in Healthy Children 4-6 Years. The trial enrolled 478 healthy children aged four to six years in the United States and was active controlled.
Yes, GSK Biologicals'Kinrix and GSK Biologicals'Kinrix® refer to the same vaccine. The registered trademark symbol is simply appended to the product name. Both names are used for the GSK plc vaccine studied for tetanus, diphtheria, and acellular pertussis in young children.